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New Guidance › Software › Cybersecurity

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

King & Spalding

NIST Releases Series of AI Guidelines & Software in Ongoing Response to AI Executive Order

King & Spalding on

The U.S. Department of Commerce’s National Institute of Standards and Technology (“NIST”) recently announced the publication of three AI guidelines as well as its release of a software package aimed at helping organizations...more

WilmerHale

NIST Issues New AI Risk Mitigation Guidelines and Software

WilmerHale on

On July 26, 2024, the National Institute for Standards and Technology (“NIST”), part of the Department of Commerce, released guidelines, a global engagement plan, and software covering various aspects of AI technology...more

Robinson+Cole Data Privacy + Security Insider

NIST Releases Guidance on Supply Chain Security

Robinson+Cole Data Privacy + Security Insider on

The National Institutes of Science and Technology (NIST) Information Technology Laboratory recently released guidance entitled “Software Supply Chain Security Guidance,” in response to directives set forth in President...more

Sheppard Mullin Richter & Hampton LLP

NIST Releases New Guidance on Software Security and Cybersecurity Consumer Labeling Programs

Sheppard Mullin Richter & Hampton LLP on

NIST recently released several key deliverables relating to cybersecurity. These focus on secure software development and new consumer labeling programs as contemplated by President Biden’s Executive Order 14028, which seeks...more

McDermott Will & Emery

Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

McDermott Will & Emery on

The US Department of Health and Human Services (HHS) has recently issued guidance under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and...more

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